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Patient Centered Machine Learning Model for Bleeding and Ischemic Risk

NCT06089304 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 19000

Last updated 2023-10-18

No results posted yet for this study

Summary

Dual antiplatelet therapy (DAPT) is indicated in all patients undergoing coronary stent implantation to prevent ischemic recurrencies despite an increased risk of bleeding. Accordingly, clinical practice guidelines advocate tailoring DAPT duration according to the patient's individual ischemic and bleeding risk profile.

Data from 11 clinical trials involving patients who underwent percutaneous coronary intervention (PCI) with an everolimus-eluting stent will be pooled and analyzed to develop a machine learning-based algorithm to predict the probability of an ischemic or bleeding event up to 1 year. These predictive risk models aim to support clinical decision-making on DAPT management after PCI.

Conditions

Interventions

DEVICE

Percutaneous coronary intervention

Percutaneous coronary intervention (PCI) is a catheter-based technique performed under fluoroscopic guidance to treat coronary artery disease and restore blood flow to the myocardium. During PCI, coronary vessel patency is generally achieved with drug-eluting stents, which are metallic scaffolds coated with a polymer that carry and gradually release an antiproliferative drug. In the present study, all participants underwent PCI with implantation of a thin-strut, cobalt-chromium, durable-fluorinated polymer, everolimus-eluting stent (XIENCE, Abbott), and received a course of dual antiplatelet therapy (DAPT) ranging from 28 to 365 days after PCI.

Sponsors & Collaborators

Principal Investigators

  • Roxana Mehran · Abbott

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2021-02-28
Completion
2023-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06089304 on ClinicalTrials.gov